MIB-725 Safety Study

Overseen By Mary F Weiss

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Metro International Biotech, LLC

Must not be taking: Barbiturates, Benzodiazepines, Opiates, others

Disqualifiers: Diabetes, Cancer, Heart failure, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a single center, open label (i.e. participants and study staff will not be masked to the intervention) single ascending dose study to evaluate the safety, tolerability, pharmaokinetics and pharmacodynamics of MIB-725 in community dwelling, healthy adults. Up to 4 successive groups (cohorts) of 8 subjects each will be enrolled in this trial. This study will determine the safety and tolerability of orally administered single ascending (increasing) doses (100, 200, 400, and 800 mg) of MIB-725 in healthy adults. The safety will be assessed by evaluating physical examination that includes an external eye examination, vital signs, adverse events, and changes in blood counts, EKG, urinalysis, coagulation measures, and blood chemistries, including but not limited to blood glucose, electrolytes, creatinine, liver function tests, uric acid, and creatine kinase.

Will I have to stop taking my current medications?

You may need to stop taking certain medications and supplements to participate in this trial. Specifically, you cannot use barbiturates, benzodiazepines, opiates, amphetamines, cannabinoids, cocaine, or any dietary supplements during the study. If you are taking a supplement with nicotinamide or similar ingredients, you must stop at least 2 weeks before the study starts.

What safety data exists for MIB-725 or similar treatments?

There is no specific safety data available for MIB-725 in the provided research articles. ^{1 2 3 4 5}

Research Team

Shalender Bhasin, MB, BS

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

This clinical trial is open to healthy adults who can participate in a study assessing the safety of a new drug called MIB-725. Participants will be part of one of four groups, each receiving different doses of the medication.

Inclusion Criteria

I am not pregnant and do not plan to become pregnant in the next 6 months.

I am a healthy adult aged 19-60 and I do not smoke.

Free from clinically significant medical problems as determined by the Investigator

Exclusion Criteria

Known allergy to niacin or nicotinamide mononucleotide

Serum creatinine > 2.0 mg/dL

Current cigarette smoker

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants receive a single ascending dose of MIB-725 (100, 200, 400, or 800 mg) to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics

1 day

1 visit (in-person) for administration and observation

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments including blood sampling and observation

4 weeks

Visits at 24 hours, 48 hours, and on Days 5, 7, 14, and 28

Treatment Details

Interventions

• MIB-725 (Other)

Trial Overview The trial is testing single increasing doses (100, 200, 400, and 800 mg) of MIB-725 to see how safe it is and how the body reacts to it. It's an open-label study where everyone knows what treatment they're getting.

Participant Groups

Group I: Safety and pharmacokinetic single dose ascending dose study Experimental Treatment 1 Intervention

This is a single dose ascending study in which 100, 200, 400, or 800 mg of MIB-725 will be administered as a single oral dose in ascending order starting with the lowest (100 mg) dose

Who Is Running the Clinical Trial?

Metro International Biotech, LLC

Lead Sponsor

Trials

5

Recruited

230+

Findings from Research

The STEP database is a new resource that compiles safety and toxicity data for excipients used in pediatric formulations, addressing the need for accessible and organized information that is often scattered across various sources.

Currently containing data from over 2000 references on 10 excipients, the database allows users to search for and by excipients, making it a unique tool for researchers and developers in ensuring the safety of pediatric medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The STEP (Safety and Toxicity of Excipients for Paediatrics) database: part 2 - the pilot version. Salunke, S., Brandys, B., Giacoia, G., et al.[2022]

In a pooled analysis of 19 clinical trials involving 4,435 patients treated with tiotropium, the drug significantly reduced the risk of dyspnea and COPD exacerbations compared to placebo, indicating its efficacy in managing obstructive lung disease.

However, tiotropium was associated with a higher risk of dry mouth and urinary retention, highlighting the importance of monitoring these side effects in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pooled clinical trial analysis of tiotropium safety. Kesten, S., Jara, M., Wentworth, C., et al.[2015]

Only 27 out of 100 newly approved pharmaceuticals had specific toxicology data available at the time of their approval, highlighting a significant gap in safety information for healthcare providers.

There was an average delay of 27.4 months for labeling revisions to include updated toxicology information, which can hinder effective treatment for patients experiencing adverse drug reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of pharmaceutical labeling for overdose treatment and toxicity data. Mazer-Amirshahi, M., Sokol, G., van den Anker, J., et al.[2013]

The Drug Adverse Reaction Database (DART) provides detailed information on 147 confirmed and 89 potential protein targets associated with adverse drug reactions (ADRs), which is crucial for understanding the mechanisms behind these reactions and aiding in drug discovery.

DART includes extensive data on 257 drugs and 1080 ligands, offering insights into their binding properties, physiological functions, and the specific adverse effects they may cause, making it a valuable resource for researchers and developers in pharmacology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug Adverse Reaction Target Database (DART) : proteins related to adverse drug reactions. Ji, ZL., Han, LY., Yap, CW., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Drug Safety Data Curation and Modeling in ChEMBL: Boxed Warnings and Withdrawn Drugs. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

The STEP (Safety and Toxicity of Excipients for Paediatrics) database: part 2 - the pilot version. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Pooled clinical trial analysis of tiotropium safety. [2015]

4. England pubmed.ncbi.nlm.nih.gov

A review of pharmaceutical labeling for overdose treatment and toxicity data. [2013]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Drug Adverse Reaction Target Database (DART) : proteins related to adverse drug reactions. [2018]